Updates From Baxter, FDA Address Hurricane Helene's Impact on IV Solutions
December 08, 2024
The Food and Drug Administration issued temporary importation approvals this month to mitigate potential shortages of intravenous (IV) solutions and peritoneal dialysis (PD) supplies. The action comes in response to significant disruptions caused by Hurricane Helene, which severely affected Baxter’s North Cove manufacturing site in North Carolina. AABB has updated the Saline Supply Shortage Toolkit with this new information.
Baxter reported that flooding from the hurricane impacted all production lines at the North Cove facility. However, the company has made strong progress in restoring operations, including restarting lines for 1-liter IV solutions, 3-liter irrigation solutions and PD solutions. Baxter noted that initial batches from these lines are only being released in accordance with applicable regulatory requirements to ensure the quality and safety of the products.
To support the health care system during this recovery period, FDA authorized temporary importation of IV and PD solutions from Baxter’s global manufacturing network. These imported products adhere to international quality standards and are being distributed alongside newly manufactured North Cove products. Additionally, Baxter is releasing one lot of sodium citrate 4% (250 ml) manufactured at the North Cove facility prior to Hurricane Helene. This lot number (Y451048) is associated with a small proportion of bags with an illegible lot number.
Baxter also emphasized its commitment to addressing patient needs by collaborating with FDA and health care providers. The company has activated nine manufacturing plants globally to supplement supply and introduced conservation strategies to manage allocation levels effectively. Baxter also continues to provide training and resources to customers handling imported products.
While Baxter aims to restore full production at North Cove by the end of 2024, the company acknowledged the complexity of the recovery effort and the ongoing importance of conservation practices.
